Neuroendocrine TumorsRMPanNETNCT04066322
Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment
An observational study of Neuroendocrine Tumors and Metastases, run by Fudan University at 1 site in China.
Trial summary
This study is to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Tumors, Metastases, Surgery
- What is being tested?
- system treatment and surgery and system treatment
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2019to 25 Jul 2025
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with metastatic pancreatic neuroendocrine tumors in a tertiary referal center
Who may be able to join
- Biopsy-proven neuroendocrine tumor
- primary site in pancreas
- Advanced disease with lymph node or distant metastases (N1, M1) cannot undergoing cytoreduction by surgery/local ablative therapy at the diagnosis
- curative intent of all therapies possible
- ECOG 0-2
Who cannot join
- Undifferentiated neuroendocrine carcinoma or mixed neuroendocrine carcinoma secondary tumor
- functioning NET or advanced carcinoid heart disease
- part of hereditary syndrome, such as MEN1, VHL
- do not willing to receive systemic treatment
- diagnosed with other cancer within 5 years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
XianJun Yu, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org
Xianjun Yu, M.D., Ph.D.
About this study
Official title: Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment: Real World Study
This study is to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment. The willing of participants decide who receive surgery and who will continue to receive standard systemic treatment.
Read the detailed description
system treatments of metastatic PanNET include SSA, sunitinib, mTOR inhibitor and chemotherapy. For patients achieved PR/SD after system treatment, resection of primary tumor and metastasis maybe a better way to decline tumor burden and get longer survival. this real world study is focused on this group of patients with metastatic PanNET, and to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment.
- Conditions
- Neuroendocrine Tumors, Metastases, Surgery
- Being tested
- system treatment and surgery, system treatment
- Medical subject headings
- Neuroendocrine Tumors, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
system treatment and surgeryProcedure or surgery
Also called resection of primary and metastatic tumors
to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to receive Synchronous resection of primary tumor and metastasis. after surgery, the investigator decide further treatments.
system treatmentOther
to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to continue take system treatment.
| Study group | Role | What they receive |
|---|---|---|
| system treatment | Patients continue to receive standard system treatment, including SSA, targeted therapy and chemotherapy. Receives: Other: system treatment | |
| system treatment and Surgery | Patients receive synchronous resection of primary tumor and metastasis after system treatment. and treatment after surgery is based on the clinical decision. Receives: Procedure: system treatment and surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 5 years
Secondary outcomes (3)
overall survival
Measured: 5 years
Number of Postoperative morbidity
Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation
Measured: Up to 90 days after operation
number of Postoperative mortality
Measured: Up to 90 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start25 Aug 2019
- Primary completion25 Jul 2024 (estimated)
- Study completion25 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066322
- Sponsor's protocol ID
- CSPAC-26
- Acronym
- RMPanNET
- Status last verified
- Sep 2019
- First submitted
- 21 Aug 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment: Real World Study
- ClinicalTrials.gov ID
- NCT04066322
- Acronym / sponsor ID
- RMPanNET / CSPAC-26
- Conditions
- Neuroendocrine Tumors, Metastases, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 25 Jul 2024 (estimated)
- Study completion
- 25 Jul 2025 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment. The willing of participants decide who receive surgery and who will continue to receive standard systemic treatment.
Detailed description
system treatments of metastatic PanNET include SSA, sunitinib, mTOR inhibitor and chemotherapy. For patients achieved PR/SD after system treatment, resection of primary tumor and metastasis maybe a better way to decline tumor burden and get longer survival. this real world study is focused on this group of patients with metastatic PanNET, and to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| system treatment | – | Other: system treatmentPatients continue to receive standard system treatment, including SSA, targeted therapy and chemotherapy. |
| system treatment and Surgery | – | Procedure: system treatment and surgeryPatients receive synchronous resection of primary tumor and metastasis after system treatment. and treatment after surgery is based on the clinical decision. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with metastatic pancreatic neuroendocrine tumors in a tertiary referal center
Key inclusion criteria (5 listed)
- Biopsy-proven neuroendocrine tumor
- primary site in pancreas
- Advanced disease with lymph node or distant metastases (N1, M1) cannot undergoing cytoreduction by surgery/local ablative therapy at the diagnosis
- curative intent of all therapies possible
- ECOG 0-2
Key exclusion criteria (5 listed)
- Undifferentiated neuroendocrine carcinoma or mixed neuroendocrine carcinoma secondary tumor
- functioning NET or advanced carcinoid heart disease
- part of hereditary syndrome, such as MEN1, VHL
- do not willing to receive systemic treatment
- diagnosed with other cancer within 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| system treatment and surgeryAlso: resection of primary and metastatic tumorsto patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to receive Synchronous resection of primary tumor and metastasis. after surgery, the investigator decide further treatments. | Procedure or surgery | system treatment and Surgery |
| system treatmentto patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to continue take system treatment. | Other | system treatment |
Primary outcome
progression-free survival
Time frame: 5 years
3 secondary outcomes
overall survival
Time frame: 5 years
Number of Postoperative morbidity
Time frame: Up to 90 days after operation
number of Postoperative mortality
Time frame: Up to 90 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Metastases, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xianjun yu, MD (+86 21 64175590, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.